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Table of Contents
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Summary of Contents for InMode Morpheus8
- Page 1 Operator Manual Morpheus8 System Version: DO609736B...
- Page 2 DO609736B Copyright © InMode Ltd. Date: December 2020 All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of InMode Ltd. �� InMode Ltd Tavor House. POB 533, Industrial Park South, Yokneam, 2069206. Israel...
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Page 3: Table Of Contents
Top Panel ......................15 Software Screens....................16 Sound Indicator ....................20 Handpieces ......................20 Section 5: System Operation ................... 23 Device Start-Up ....................23 System Shutdown ....................23 Section 6: Morpheus8 Treatment Information ............24 Sub-dermal Fractional Treatment ................ 24... - Page 4 Indications for Use ....................24 Contraindications ....................24 Possible Adverse Side Effects ................26 Pre-treatment Recommendations ............... 26 Test Spots ......................27 Treatment Recommendations ................29 Treatment Schedule ..................... 30 Post-treatment Recommendations ..............31 Section 7: Troubleshooting ..................32 Description of Faults with All Handpiece ............. 32 Section 8: System Specifications ................
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Page 5: Section 1: Introduction
System. System Overview The InMode RF Pro Platform with the Morpheus Handpieces marketed as Morpheus8 System and employs bi-polar Radio-frequency (RF) technology for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis for various aesthetic applications. -
Page 6: Explanation Of The Symbols Used On The System
Morpheus8 System Operator Manual Section 1: Introduction Explanation of the Symbols used on the System Symbol Description CSA marking (212603 CSA master contract number) Do not discard in trash. Electronic equipment should be disposed of in an appropriate manner Fuse... -
Page 7: Section 2: Safety
Patients will not be in contact with any metal or other alternate pathway to ground whilst the System is in use. Treating Attendant ▪ Only authorized individuals with appropriate training and knowledge should operate, assist in the operation of, or provide maintenance to the Morpheus8 System. 3 of 39... -
Page 8: Cautions
Morpheus8 System Operator Manual Section 2: Safety ▪ Personnel should not operate the System until they have been fully educated in its use. Make sure that all treatment personnel are familiar with the System controls and know how to shut down the System instantly. -
Page 9: Safety Features Of The System
Morpheus8 System Operator Manual Section 2: Safety ▪ Keep drapes and towels moist to prevent them from igniting and burning. Use nonflammable prepping solutions. ▪ If alcohol is used for cleaning and disinfecting, it must be allowed to dry thoroughly before the System is used. -
Page 10: Warnings
This equipment is for use only by qualified medical professionals trained in the particular technique to be performed. Only Handpieces manufactured or approved by InMode Ltd. should be used with Morpheus8 System. Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit. -
Page 11: System And Handpieces Labels
The RF energy and heating associated with the System can provide an ignition source. Observe fire precautions at all times. When using Morpheus8 System in the same room with any of these substances or gases, prevent their accumulation or pooling within the area where Morpheus8 procedures are performed. - Page 12 Morpheus8 System Operator Manual Section 2: Safety Figure 2-2: Device label Figure 2-3: Footswitch label The Handpieces certifications and identification labels are attached to connectors on the Handpieces. It states that the product conforms to the performance standards, and indicates the manufacturer’s name, date of manufacturing, model and serial number of the Handpiece.
- Page 13 Morpheus8 System Operator Manual Section 2: Safety Figure 2-4: Morpheus8 Applicator(left) and Morpheus8 Body (right) Identification Labels Figure 2-5: Morpheus8 Tip Identification Label Figure 2-6: Morpheus8 Body Tip Identification Label 9 of 39...
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Page 14: 2.10 Equipment Classification
Not suitable for use in presence of flammable substance. ▪ Power receptacle must include protective earth and must be checked before connecting the System. The Morpheus8 System is classified as Class II device defined by the FDA CDRH and complies with 21 CFR subparts E. 10 of 39... -
Page 15: Section 3: System Installation
Morpheus8 System Operator Manual Section 3: System Installation Section 3: System Installation Electrical Requirements ▪ The System will require a separate line supply of single phase (100Vac; 10A) or (115Vac; 10A) or (230Vac; 10A) or (240Vac; 10A) 50-60Hz. ▪ Power receptacles must be within 15 feet of the System site. -
Page 16: Unpacking
Morpheus8 System Operator Manual Section 3: System Installation Unpacking In order to unpack the device: 1. Remove the paper strip and open the box 2. Remove accessories and foams around the device. 3. Take device out of the box using top and bottom handles. -
Page 17: Installation
Morpheus8 System Operator Manual Section 3: System Installation Installation The System is designed for installation in a clinic environment. To install the System, perform the following tasks: ▪ Check the System and all its components for damage. ▪ Connect cradle to the device. -
Page 18: Section 4: Device Description
Morpheus8 System Operator Manual Section 4: Device Description Section 4: Device Description Rear Panel Power Cord Inlet 100-240V~, 15A, 50-60Hz. Fuse Holder Rating is T 12A, 250V. Replace fuses if needed, only with fuses having exactly the same rating. Software Flash Memory Plug The software plug is a flash memory with the machine software. -
Page 19: Top Panel
Morpheus8 System Operator Manual Section 4: Device Description Top Panel The top panel consists of Applicator Connector and Software Flash Memory Plug (Green area in Figure 4.2). On the corners of the top panel there are four cradle connectors. Figure 4-2: Schematic Top View of the System Power On-Off switch Power switch turns system on and off –... -
Page 20: Software Screens
Morpheus8 System Operator Manual Section 4: Device Description Software Screens The Progress screen appears after the On-Off switch is turned on. Figure 4-3: Progress Screen *The SW version number will be displayed according to the software version. After entering the individual code on the Login Screen, non-authorized use of the device is prevented.
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